Following the first workshop on Nov. 17, 2021, Cardinal Health is getting well into onboarding its’ suppliers in preparation for their strategic November 2022 deadline. With that comes working through the EPCIS issues that are both expected and unexpected. To that end, LSPediA and Cardinal Health held the second Investigator Virtual Workshop Wednesday, Dec. 15.
Cardinal Health Manager of Pharmaceutical Information Technology Jeff Falardeau continued the conversation from the first workshop and delved into the onboarding process.
Using LSPediA’s Investigator, Cardinal Health is finding errors beyond what the human eye can see.
“There were some outright violations that stopped documents from processing, and we were somewhat flying blind for a while with at least 100 documents a day,” Falardeau said. “The only way to evaluate that is to have some kind of automation behind it.
“Some manufacturers expressed frustration because we didn’t track these errors before – and that was because we didn’t have the capacity to find things like this manually,” Falardeau added. “Now that we can, it’s good news for everyone, and we hope our manufacturers will share the enthusiasm for finding good data quality.”
As Falardeau previously mentioned, Cardinal Health has set a November 2022 deadline for its’ suppliers to be sending aggregated serialized EPCIS data. That is a full year ahead of the FDA’s 2023 requirement. The reason is because Cardinal Health needs time to ensure stabilization in the supply line to dispensers.
“If we get to 2023 and we don’t get high quality data, there is a possibility that the product will be returned to the manufacturer,” said Falardeau. “That would create costs for both parties, and prevents product from getting to patients in a timely fashion. That’s one reason why we’re looking to get data from suppliers a year in advance.”
Falardeau noted that Cardinal Health’s role is to offer as much help to suppliers as possible. For those who are not yet using LSPediA’s Investigator, Cardinal Health will sponsor a notification account per supplier at no charge to the manufacturer.
“There is an annual registration fee for Investigator, but Cardinal will sponsor a notification account for any supplier that needs one. With a distribution list as the Point of Contact, we can notify an army of people, ” Falardeau said. He also mentioned that the notification account should be owned by someone who is has working knowledge of EPCIS.
Falardeau has seen great success so far in using Investigator and encouraged suppliers to as well to increase efficiency.
“Investigator will check for errors and do a much more thorough job than we (Cardinal Health IT) can do with manual investigation,” Falardeau said. “It will save a ton of time, and that’s good for me, good for you, and good for patients. It eliminates the potential for human error and gives time back to work on other value-added tasks.
“Prior to Investigator we were limited to discover errors that we could see. The errors that we can’t see often cause issues downstream. With Investigator, we now catch more errors upfront,” Falardeau added. “By participating in the workshop, you can see your errors first-hand and work on them when you have the time. It’s good practice for 2023.”
Cardinal Health will issue new guide versions for suppliers in January on the Cardinal Tracing Webpage. Authorized suppliers may access the Investigator Workshop SharePoint for recordings, presentations, and documents. The next Cardinal Health Investigator Workshop will be held January 19. Register here LSP Webinar Registration.
Investigator is the go-to exceptions management solution for the FDA’s Enhanced Supply Chain Security requirement, a 2023 mandate under the Drug Supply Chain Security Act (DSCSA). It manages the errors and failures that arise from new DSCSA transactions including EPCIS and VRS. Without Investigator, supply chain exceptions that are not resolved in a timely manner present severe compliance and business risks:
- Compliance gaps – FDA’s Enhanced Security requirement
- Issues and errors in the supply chain – EPCIS and VRS exceptions
- Overwhelming workload – error detection and resolution are complex and resource intensive